K063546 is an FDA 510(k) clearance for the INSUFLOW DEVICE, MODEL 6198. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on January 10, 2007, 47 days after receiving the submission on November 24, 2006.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K063546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2006 |
| Decision Date | January 10, 2007 |
| Days to Decision | 47 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF - Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |